Kornimate/medical-research-clean huggingface dataset:
.patient blood management program in liver transplantation

Conditions: Iron Deficiency Anemia

Summary: transfusion management improvement programs, generally known as patient blood management (pbm) programs, are based on a set of perioperative measures aimed at improving clinical outcomes by avoiding unnecessary exposure to blood components. in a recent series of liver transplants (lt) performed in spanish centers belonging to the spanish liver transplant society, despite optimal hemostasis management and preservation of the vena cava, around 20% of patients required massive transfusion (considered as the administration of 6 or more red blood cell concentrates intraoperatively). in addition, 63% of the patients were transfused with at least one packed red cells during the operation. by correcting the iron deficiency in patients who meet the criteria of the anemia study (transferrin saturation less than 20%), we could improve the hemoglobin level, which would allow a wider margin for the transfusion of red cell concentrates.

this is a prospective observational multicenter study to evaluate the efficacy of iron administration in patients candidates to lt. inclusion criteria patients with hb \ 40% will constitute the control group. the intraoperative managed protocol was standardized within groups and teams. demographic and liver function test after iron administration will be registered; perioperative transfusion data will be recorded. recruitment, treatment and follow-up will be conducted by monitored by an independent audit to assure the quality of data. specific data unit not related to the participated teams will do statistical analysis. the primary outcome is the feasibility of apply the first pillar of the patient blood management programs (pbm) in lt candidates. secondary outcomes are the response rate (increase in hb \> 1 g/dl) to the intervention, and red blood cell requirements in both, intervention and control group

Eligibility criteria:
inclusion criteria: * liver cirrhosis on the liver transplant waiting list * haemoglobin lower than 11.5g/dl * transferrin saturation index below 40% * ferritin below 800mcg/l exclusion criteria: * refusal to participate * known hypersensitivity to ferinject * current infection

Keywords: iron deficiency liver transplantation intravenous iron
efficacy and safety of sofosbuvir/velpatasvir fixed-dose combination in participants with chronic hepatitis c virus infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (sof/vel) fixed-dose combination (fdc) for 12 weeks in participants with chronic hepatitis c virus (hcv) infection.


Eligibility criteria:
key inclusion criteria: * hcv rna ≥ 10\^4 iu/ml at screening * chronic hcv infection (≥ 6 months) documented by prior medical history or liver biopsy key exclusion criteria: * any other chronic liver disease * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * clinical hepatic decompensation * prior exposure to sof or other nucleotide analogue hcv ns5b inhibitor or any hcv ns5a inhibitor note: other protocol defined inclusion/ exclusion criteria may apply.
e-nose and colorectal cancer

Conditions: Colorectal Cancer; Polyps

Summary: colorectal cancer (crc) is the third most common new cancer diagnosis and a major cause of morbidity and mortality throughout the world. early detection and treatment are critical factors in the course and prognosis of crc, and screening programs have proven to be an important means to reduce both crc related mortality and secondary economic burden. the diagnostic accuracy of non-invasive screening tests is still limited and a follow-up colonoscopy is required for confirmation of the diagnosis. the faecal occult blood test (fit) is the most commonly used fecal screening test worldwide, but sensitivity for crc ranges between 53%-99% depending on the cut-off values used, whereas sensitivity for advanced adenomas is disturbingly low (39%-57%). the aim of this study is to evaluate the diagnostic accuracy of the aeonosetm to distuinguish people with crc from healthy controls.

rationale: an electronic nose (enose) is an artificial olfactory system that analyses volate organic compounds (vocs) in exhaled breath. exhaled human breath is mainly composed of inorganic compounds, inert gases and vocs. vocs are exhaled in very low concentrations and reflect pathological processes such as inflammation, oxidation, infection and neoplasms. the perspective is that metabolic and biochemical processes in several pathological situations cause different endogenous vocs to arise, were they can serve as non-invasive biomarkers for certain diseases. primary objective: to evaluate the diagnostic accuracy of the aeonosetm to distinguish the breathing pattern from patients with colorectal cancer from healthy controls using the previously established breathing pattern. secondary objecitves: * to evaluate the diagnostic accuracy of the aeonosetm to distinguish the breathing pattern from patients with polyps (e.g. advanced adenomas, sessile serrated lesions). * to determine the influence of colonic cleansing (laxative use) on breathing patterns. study population: adult patients referred for colonoscopy. estimated sample size: 66 patients with crc. intervention: participants will be asked to breath through the aeonosetm for 5 minutes. there are no risks, nor benefits for the participants.

Eligibility criteria:
inclusion criteria: * 18 years or older * suspicion for (pre-)malignant lesions of the colon scheduled for colonoscopy exclusion criteria: * subjects with other known malignancies * subjects with established inflammatory bowel disease
exercise time in sedentary middle-aged female

Conditions: Weight Loss

Summary: the exercise time is an important factor among the medical guides for weight loss; however, there is still little knowledge about exercise duration paths in middle-aged and older women. the present study aimed to determine the effects of the interval training on weight loss and lipid profile, and to compare its efficiency with the continuous training.

participants included sedentary women (age 45-75 years) with overweight or obesity (n= 115). they were randomly divided into two groups including continuous exercise, and interval exercise. the weight assessment parameters including change in weight and body composition, blood sample tests were performed pre- and three month post-intervention.

Eligibility criteria:
inclusion criteria: * sedentary lifestyle * good health * weight stability exclusion criteria: \*abnormality or history of disease
low glycemic diet intervention and community diabetic patients

Conditions: Diabetes

Summary: the purpose of this study is to investigate the efficiency of nutrition education-based low glycemic diet intervention on community diabetic patients. design: randomized clinical trial. main measures: hba1c,fasting blood glucose(fbg),2 hours postprandial blood glucose（2hpg）

low glycemic diet can help to control blood glucose levels，this study is to investigate the efficiency of nutrition education-based low glycemic diet intervention on community diabetic patients,and to improve health outcomes of patients with type 2 diabetes mellitus (t2dm) by influencing disease self-management through lifestyle modification and diet controlling.

Eligibility criteria:
inclusion criteria: * subject has a fasting blood glucose between 6.1 and 6.9mmol/l or diagnosed of type 2 diabetes * glycosylated hemoglobin(a1c) between 6 and 11%. * subject's age≥18 years. exclusion criteria: * subject has kidney disease (defined as creatinine\>1.3 mg/dl) * active liver or gallbladder disease * significant heart disease * a history of severe hypoglycemia, or use of weight loss medications. * subject that is pregnant.

Keywords: low glycemic diet diabetes
fibrinogen for treatment of pediatric dilutional coagulopathy. fibpaed study.

Conditions: Blood Coagulation Disorders; Hemorrhage

Summary: the purpose of this study is to compare two different thromboelastometry (rotem) trigger levels for administration of human fibrinogen concentrate (haemocomplettan p) in the treatment of perioperative dilutional coagulopathy during major pediatric surgery. the study hypothesis is that administration of fibrinogen concentrate triggered by a rotem fibtem mcf \< 13 mm might reduce the total amount of transfused red cell concentrate during 24 hours after start of surgery as compared to a trigger level of rotem fibtem mcf \< 8 mm.


Eligibility criteria:
inclusion criteria: * males and females * age 6 months to 17 years * scheduled for elective scoliosis surgery or major craniofacial surgery * written informed consent has been obtained * intraoperative hypofibrinogenemia according to definition of treatment groups exclusion criteria: * preexisting congenital or acquired coagulation disorder * medical history of estimated increased bleeding tendency * ongoing coagulation therapy * clinical signs or diagnosis of acute thromboembolism * intolerance of study drug * participation at another clinical trial * pregnant or lactating women

Keywords: fibrinogen blood coagulation disorders postoperative bleeding transfusions
to evaluate the safety of long-term use of hpn-100 in the management of urea cycle disorders (ucds)

Conditions: Urea Cycle Disorders

Summary: this was an open-label, long-term safety study of hpn-100 (ravicti; glycerol phenylbutyrate) in participants with a urea cycle disorder (ucd) who completed the safety extensions of hpn-100-005 (nct00947544; hpn-100-005se), hpn-100-006 (nct00947297; hpn-100-007), or hpn-100-012 (nct01347073; hpn-100-012se). the initial studies were 1- to 2-week crossover studies, and their associated safety extensions were 12-month, open-label studies. all participants who completed the initial studies were eligible to enroll in the associated safety extension studies, and new participants were also permitted to enroll directly into the safety extension studies.

the duration of treatment in this study was open-ended. participants were to return for clinic visits as prescribed by the investigator, and were to be seen at a minimum of every 6 months. at each clinic visit, participants were queried about any adverse events (aes) or hyperammonemic crises (hacs) that occurred since the last visit. physical and neurological examinations were performed, and blood samples were collected for the analysis of ammonia, amino acid panels, and routine clinical laboratory safety tests. participants underwent neuropsychological testing at baseline, every 12 months thereafter, and at the final study visit. study acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * male and female subjects who completed studies hpn-100-005se, hpn-100-007, or hpn-100-012se * signed informed consent by participant and/or participant's legally authorized representative * negative pregnancy test for all females of childbearing potential exclusion criteria: * any clinical or laboratory abnormality or medical condition that, at the discretion of the investigator, may have put the participant at increased risk when participating * known hypersensitivity to paa (phenylacetate) or pba (phenylbutyrate). * liver transplant, including hepatocellular transplant * pregnant, breastfeeding or lactating females

Keywords: urea cycle disorders gt4p hpn-100 sodium phenylbutyrate (napba) glyceryl tri-(4-phenylbutyrate) phenylbutyrate hyperion buphenyl hyperammonemia
retrospective study of the relationship between human papillomavirus genotype and cervical epithelial lesions

Conditions: Cervical Cancer

Summary: human papillomavirus (hpv) infection plays a key role in the carcinogenesis of cervical cancer and pre-invasive lesions. there are hundred types of hpv, including high risk and low risk types, and it is proved the close association between the cervical cancer and high risk hpv. while hpv 16 and 18 are known to be the leading two genotypes detected in women with cervical neoplasm worldwide, there is considerable difference in the other prevalent high risk genotypes in different geographic areas. it is important to establish the local database about the cervical intraepithelial lesions and the related prevalent hpv genotypes. the investigators designed a retrospective study which included total 784 patients managed at our hospital from january 1, 2000 to december 31, 2007. the present study was to investigate the hpv genotypes in the taiwanese female patients with abnormal cervical cytology and analyses the association between hpv types and cervical pre-invasive lesions. it could provide the guide for the clinicians in the management of patients with abnormal cytological change of pap smear.


Eligibility criteria:
inclusion criteria: * healthy volunteers * people infected with hpv type 16 but without cin lesions * patients with cin lesions * patients with cervical cancer from national taiwan university hospital * informed consent is obtained, and the protocols are reviewed and approved by the appropriate investigative review boards. exclusion criteria: * none
strengthening community mental health

Conditions: Mental Health; Emotional Wellbeing; Anxiety; Depression; Stress; Coping; Perceived Stress; Perceived Social Support

Summary: the goal of this clinical trial is to examine the impact of the communities organizing for power through empathy (cope) intervention in adults in communities having recently experienced or at risk of experiencing disaster. the main questions it aims to answer are: * how does the cope intervention affect individual mental health? * how does the cope intervention affect protective factors like coping and social support? * how does the cope intervention affect community resilience? * how does delivery of the cope intervention in partnership with a broad-based organization affect participant recruitment and retention, as well as outcomes? participants will participate in the three session cope intervention. researchers will compare individuals who participate in the cope intervention to individuals who participate in house meetings to see if the cope intervention improves mental health, coping, social support and community resilience. researchers will also examine factors that affect implementation and intervention delivery.

this community-based participatory research (cbpr) study will follow a multiphase mixed-methods design to adapt, deliver, and assess the efficacy of the communities organizing for power through empathy (cope) intervention model. we will partner with a broad-based community organization, together baton rouge, to adapt the intervention model to fit the context of east baton rouge parish (ebrp) and deliver it to members of religious and non-profit institutions. the objectives of the multi-level cope intervention model are twofold: (1) reduce psychological distress and amplify protective factors among individuals and communities at risk of experiencing disasters; and (2) build individual and community psychological support response capacity. the intervention will be delivered by trained community facilitators (cfs) at community institutions (i.e., churches) to their institutional members. we will conduct a stepped wedge cluster randomized controlled trial (swcrct) to examine the impact of the cope intervention. measures of mental health, coping, social support and community resilience will be assessed at four timepoints (see timeline for data collection timepoints). we will conduct interviews and group reflections with cfs and participants to gain insight into their experiences with the intervention.

Eligibility criteria:
inclusion criteria: * individuals 18 years of age or older who are staff or members of an organization that is part of together baton rouge and who participate in the intervention or are/were involved in the adaptation or implementation of the brief intervention in any capacity exclusion criteria: * persons who are not 18 years of age or older and persons who are not staff or members of an organization that is part of together baton rouge and/or not involved with the intervention

Keywords: mental health community-based participatory research emotional wellbeing perceived stress
tthx1114(nm141) in combination with dwek/dso

Conditions: Fuchs' Endothelial Dystrophy; Fuchs Dystrophy; Fuchs

Summary: open label, single-treatment, with a concurrent non-treatment control


Eligibility criteria:
key inclusion criteria: * fuchs endothelial cell dystrophy (fecd) diagnosed more than 6 months * scheduled for dwek/dso with a planned central descemetorhexis of approx 4 to 5 mm * subjects in group 2 must have a stable fellow eye with adequate function key exclusion criteria: * secondary corneal/ocular pathology in the study eye * prior refractive surgery in the study eye * prior exposure to tthx1114
prediction of childhood epilepsy outcome in bangladesh

Conditions: Epilepsy

Summary: randomised controlled trial of the use of phenobarbitone and carbamazepine in childhood epilepsy in bangladesh with particular reference to behavioural side effects.


Eligibility criteria:
inclusion criteria: * active epilepsy * aged 2-15 years exclusion criteria: * excluded absence * myoclonic and malignant epilepsy syndromes * major motor and cognitive impairments * those currently receiving antiepilepsy drugs.

Keywords: childhood epilepsy active childhood epilepsy
effect of reformer exercises on pain perception in chronic musculoskeletal pain.

Conditions: Musculoskeletal Pain

Summary: this study was planned to investigate whether reformer pilates exercises, which are recommended for the development and maintenance of well-being in musculoskeletal problems associated with low back, neck and back pain, change the pain perceptions of patients with chronic musculoskeletal diseases by improving the mind-body relationship.

although many symptoms are observed in musculoskeletal system disorders, pain which progresses gradually and even progresses to the point of causing incapacity for work is the most common. although musculoskeletal system disorders indicate a very broad concept, it is also observed that low back, neck and back pain are in the first rank in studies conducted worldwide and in our country .pilates training plays an important role in regaining and maintaining muscle strength, flexibility, endurance and functioning of proprioceptive mechanisms. although there are many physical activity programmes, pilates has become an increasingly widespread and recommended physical exercise method worldwide in recent years. the pilates method is an exercise concept established by joseph h pilates in the early 1900s and currently applied to both sick and healthy individuals. exercises can be performed on a mat and special equipment such as cadillac, reformer and wundachair are also used. pilates training plays an important role in regaining and maintaining muscle strength, flexibility, endurance and functioning of proprioceptive mechanisms. therefore, although pilates exercises are not designed to reduce body weight, they are a good option for sedentary, overweight and obese people who have difficulty in performing traditional exercises . this study was planned to investigate whether reformer pilates exercises, which are recommended for the development and maintenance of well-being in musculoskeletal problems associated with low back, neck and back pain, change the pain perceptions of patients with chronic musculoskeletal diseases by improving the mind-body relationship.

Eligibility criteria:
inclusion criteria: sedantry male and female aged 30-50 years chronic musculoskeletal pain diagnosed for at least 6 months exclusion criteria: neurological disorders communication and psychiatric disorders

Keywords: chronic pain musculoskeletal pain reformer pilates
dare: diabetes in cardiac rehabilitation

Conditions: Type 2 Diabetes Mellitus; Coronary Artery Disease

Summary: the aim of the dare study is to see whether strict glycemic control during cardiac rehabilitation may ameliorate the improvement of exercise capacities (vo2 peak, peak workload, ventilatory threshold)in patients with type 2 diabetes with coronary artery disease.

in a recent study, we showed that the benefit of cardiac rehabilitation on the improvement of exercise capacities (vo2 peak, peak workload, ventilatory threshold), after an acute coronary event, was significantly reduced in patients with type 2 diabetes. moreover ,we showed, in multivariate analysis, that the worse improvement of the capacities to the effort after cardiac rehabilitation, was mainly related to hyperglycemia. because the improvement of exercise capacities after cardiac rehabilitation (in particular vo2 peak) has been shown to be an essential factor to reduce short- term and long-term morbidity and mortality, we may think that such benefit on reduction of morbidity and mortality may be significantly less in patients with diabetes. thus, we propose to carry out a multicentric intervention study, entitled dare which goal is to see whether a strict glycemic control, during cardiac rehabilitation following an acute myocardial infarction (mi), is likely to improve, the results of cardiac rehabilitation on exercise capacities in patients with type 2 diabetes. after arrival in cardiac rehabilitation, patients with diabetes, will be randomized into 2 groups: an "intensive treatment" group, in which the patients will treated by insulin under a basal-bolus regimen with strict glycemic control and a "conventional treatment" group, in which the previous anti-diabetic treatment will be continued.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * recent miocardial infarction * hba1c above 7% * enrolled in a cardiac rehabilitation program exclusion criteria: * type 1 diabetes * coronary bypass surgery * renal failure (creatinine clearance below 30 ml/min) * severe respiratory failure

Keywords: diabetes mellitus cardiac rehabilitation insulin
long-term treatment on bay77-1931 (lanthanum carbonate) to measure lanthanum concentrations in bone

Conditions: Hyperphosphatemia; Dialysis

Summary: to measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis


Eligibility criteria:
inclusion criteria: * patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication exclusion criteria: * patients with severe hypocalcemia (adjusted serum calcium level of \<7.5 mg/dl)